Molnupiravir Use and 30-Day Hospitalizations or Death in Previously Uninfected Non-hospitalized High-risk Population with COVID-19

Butt et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiad195

Jun 2023

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Retrospective 65,010 veterans in the USA, showing no significant difference in hospitalization/death with molnupiravir treatment. 1,729 patients received molnupiravir. Authors emulate a target trial closely matching the MOVe-OUT RCT and using 1,459 matched pairs.

Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer1-9. Multiple analyses have identified variants potentially created by molnupiravir10-13.

Important missing comments or errors? Let us know.

risk of death/hospitalization, 9.1% higher, RR 1.09, p = 0.75, treatment 48 of 1,459 (3.3%), control 44 of 1,459 (3.0%).

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

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5. Zibat et al., N4-hydroxycytidine, the active compound of Molnupiravir, promotes SARS-CoV-2 mutagenesis and escape from a neutralizing nanobody, iScience, doi:10.1016/j.isci.2023.107786.sciencedirect.com, doi.org.

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8. Zhou et al., β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells, The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247.oup.com, doi.org.

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Butt et al., 1 Jun 2023, retrospective, USA, peer-reviewed, 6 authors.

This Paper Molnupiravir All

Molnupiravir Use and 30-Day Hospitalizations or Death in a Previously Uninfected Nonhospitalized High-risk Population With COVID-19

MBBS Adeel A Butt, MS Peng Yan, MD Obaid S Shaikh, MD, MPH Saad B Omer, MD Florian B Mayr, PhD Victor B Talisa

The Journal of Infectious Diseases, doi:10.1093/infdis/jiad195

Background: Clinical benefit of Molnupiravir (MPV) in COVID-19 infected sub-populations is unclear. Methods: We used a matched cohort study design to determine the rate of hospitalization or death within 30 days of COVID-19 diagnosis among MPV treated and untreated controls.

Author Contributions Study concept and study design: Role of the Funding Source There was no funding source. Data Access Drs. Butt and Mr. Yan had complete access to the data at all times and accept responsibility for the integrity of this article.

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Participants were nonhospitalized, previously uninfected Veterans with a first ' 'confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection between 1 ' 'January and 31 August 2022, who were prescribed MPV within 3 days of COVID-19 diagnosis, and ' 'matched individuals who were not prescribed MPV.\n' ' \n' ' \n' ' Results\n' ' Among 1459 matched pairs, the incidence of hospitalization/death ' 'was not different among MPV treated versus untreated controls (48 vs 44 cases; absolute risk ' 'difference [ARD], 0.27; 95% confidence interval [CI], −.94 to 1.49). No benefit was observed ' 'among those &gt;60 or ≤60 years old (ARD, 0.27; 95% CI, −1.25 to 1.79 vs ARD, −0.29; 95% ' 'CI, −1.22 to 1.80), those with specific comorbidities, or by vaccination status. A ' 'significant benefit was observed in asymptomatic but not in symptomatic persons (ARD, −2.80; ' '95% CI, −4.74 to −.87 vs ARD, 1.12; 95% CI −.31 to 2.55). Kaplan-Meier curves did not show a ' 'difference in proportion of persons who were hospitalized or died among MPV treated compared ' 'with untreated controls (logrank P = .7).\n' ' \n' ' \n' ' Conclusions\n' ' MPV was not associated with a reduction in hospitalization or death ' 'within 30 days of COVID-19 diagnosis. 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'key': '2023101809355295300_jiad195-B32', 'doi-asserted-by': 'crossref', 'first-page': '100602', 'DOI': '10.1016/j.lanwpc.2022.100602', 'article-title': 'Association of molnupiravir and nirmatrelvir-ritonavir with preventable ' 'mortality, hospital admissions and related avoidable healthcare system ' 'cost among high-risk patients with mild to moderate COVID-19', 'volume': '30', 'author': 'Wai', 'year': '2023', 'journal-title': 'Lancet Reg Health West Pac'}, { 'key': '2023101809355295300_jiad195-B33', 'doi-asserted-by': 'crossref', 'first-page': '183', 'DOI': '10.1016/S1473-3099(22)00644-2', 'article-title': 'Molnupiravir versus placebo in unvaccinated and vaccinated patients ' 'with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, ' 'placebo-controlled, double-blind, phase 2 trial', 'volume': '23', 'author': 'Khoo', 'year': '2023', 'journal-title': 'Lancet Infect Dis'}, { 'key': '2023101809355295300_jiad195-B34', 'doi-asserted-by': 'crossref', 'first-page': '453', 'DOI': '10.1093/cid/ciac781', 'article-title': 'Effectiveness of molnupiravir in high risk patients: a propensity score ' 'matched analysis', 'volume': '76', 'author': 'Najjar-Debbiny', 'year': '2023', 'journal-title': 'Clin Infect Dis'}, { 'key': '2023101809355295300_jiad195-B35', 'doi-asserted-by': 'crossref', 'first-page': 'e849', 'DOI': '10.1093/cid/ciab1023', 'article-title': 'Rate and risk factors for severe/critical disease among fully ' 'vaccinated persons with breakthrough severe acute respiratory syndrome ' 'coronavirus 2 (SARS-CoV-2) infection in a high-risk national population', 'volume': '75', 'author': 'Butt', 'year': '2022', 'journal-title': 'Clin Infect Dis'}, { 'key': '2023101809355295300_jiad195-B36', 'doi-asserted-by': 'crossref', 'first-page': '1375', 'DOI': '10.1056/NEJMc2200415', 'article-title': 'Effectiveness of homologous or heterologous COVID-19 boosters in ' 'veterans', 'volume': '386', 'author': 'Mayr', 'year': '2022', 'journal-title': 'N Engl J Med'}, { 'key': '2023101809355295300_jiad195-B37', 'doi-asserted-by': 'crossref', 'first-page': '3647', 'DOI': '10.1038/s41467-022-31402-4', 'article-title': 'COVID-19 disease severity in US veterans infected during omicron and ' 'Delta variant predominant periods', 'volume': '13', 'author': 'Mayr', 'year': '2022', 'journal-title': 'Nat Commun'}, { 'key': '2023101809355295300_jiad195-B38', 'doi-asserted-by': 'crossref', 'first-page': '352', 'DOI': '10.7326/M21-3256', 'article-title': 'COVID-19 vaccination effectiveness against infection or death in a ' 'national U.S. health care system: a target trial emulation study', 'volume': '175', 'author': 'Ioannou', 'year': '2022', 'journal-title': 'Ann Intern Med'}, { 'key': '2023101809355295300_jiad195-B39', 'doi-asserted-by': 'crossref', 'first-page': '2161', 'DOI': '10.1093/cid/ciac328', 'article-title': 'Relative vaccine effectiveness of a SARS-CoV-2 mRNA vaccine booster ' 'dose against the omicron variant', 'volume': '75', 'author': 'Butt', 'year': '2022', 'journal-title': 'Clin Infect Dis'}, {'key': '2023101809355295300_jiad195-B40', 'author': 'SAS Institute'}, { 'key': '2023101809355295300_jiad195-B41', 'first-page': '100089', 'article-title': 'The regrettable story of the “COVID kit” and the “early treatment of ' 'COVID-19” in Brazil', 'volume': '4', 'author': 'Furlan', 'year': '2021', 'journal-title': 'Lancet Reg Health Am'}, { 'key': '2023101809355295300_jiad195-B42', 'doi-asserted-by': 'crossref', 'first-page': '747', 'DOI': '10.2147/IDR.S351827', 'article-title': 'Azithromycin misuse during the COVID-19 pandemic: a cross-sectional ' 'study from Jordan', 'volume': '15', 'author': 'Abdelmalek', 'year': '2022', 'journal-title': 'Infect Drug Resist'}, { 'key': '2023101809355295300_jiad195-B43', 'doi-asserted-by': 'crossref', 'first-page': '6463', 'DOI': '10.1016/j.vaccine.2022.09.046', 'article-title': 'Misinformation about vaccine safety and uptake of COVID-19 vaccines ' 'among adults and 5–11-year-olds in the United States', 'volume': '40', 'author': 'Romer', 'year': '2022', 'journal-title': 'Vaccine'}, { 'key': '2023101809355295300_jiad195-B44', 'doi-asserted-by': 'crossref', 'first-page': '13681', 'DOI': '10.1038/s41598-022-17430-6', 'article-title': 'Misinformation of COVID-19 vaccines and vaccine hesitancy', 'volume': '12', 'author': 'Lee', 'year': '2022', 'journal-title': 'Sci Rep'}, { 'key': '2023101809355295300_jiad195-B45', 'doi-asserted-by': 'crossref', 'first-page': '431', 'DOI': '10.1186/s12913-015-1069-8', 'article-title': 'Dual use of VA and non-VA hospitals by veterans with multiple ' 'hospitalizations', 'volume': '15', 'author': 'West', 'year': '2015', 'journal-title': 'BMC Health Serv Res'}], 'container-title': 'The Journal of Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/jid/advance-article-pdf/doi/10.1093/infdis/jiad195/50600051/jiad195.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/jid/article-pdf/228/8/1033/52210066/jiad195.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/jid/article-pdf/228/8/1033/52210066/jiad195.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 10, 18]], 'date-time': '2023-10-18T09:37:52Z', 'timestamp': 1697621872000}, 'score': 1, 'resource': {'primary': {'URL': 'https://academic.oup.com/jid/article/228/8/1033/7187858'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 6, 1]]}, 'references-count': 45, 'journal-issue': { 'issue': '8', 'published-online': {'date-parts': [[2023, 6, 1]]}, 'published-print': {'date-parts': [[2023, 10, 18]]}}, 'URL': 'http://dx.doi.org/10.1093/infdis/jiad195', 'relation': {}, 'ISSN': ['0022-1899', '1537-6613'], 'subject': ['Infectious Diseases', 'Immunology and Allergy'], 'published-other': {'date-parts': [[2023, 10, 15]]}, 'published': {'date-parts': [[2023, 6, 1]]}}

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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.

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